InSurg: The Inselspital Surgical Cohort Study
Study Details
Study Description
Brief Summary
Personalizing surgical care is of enormous clinical relevance, when considering the number of patients undergoing surgery in Switzerland every year. Currently, personalization is based on underlying or coexisting disease or alterations of laboratory values, but there is no accepted biological test available that may predict success or failure of surgery. Surgical site infections are the most common form of hospital-acquired infections. While the relevance of bacteria, antibiotics and intensive care support is well accepted, the impact of the individual host response remains poorly understood. The Investigators hypothesize that postoperative alterations of the metabolome allow identification of predictors of surgical complications in general, and surgical site infections in particular.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The investigators will conduct a prospective cohort study aiming to identify the metabolic and genetic signature that is associated with surgical site infections. Secondary aims and outcomes include the influence of metabolome on response to anesthetic drugs and acute and chronic pain, surgery- and anesthesia-factors related to short- and long-term oncological outcome, metabolic response effect on infectious complications and rejection after transplantation, bacteria-specific immune responses to major surgery after 2-4 weeks after surgery, metabolomics and macrobiotic markers for postoperative ileus or anastomotic leakage, and the effect of the presence of multidrug resistant bacteria on surgical outcome. All patients undergoing surgery in the investigators' clinic and who gave informed consent will be included. A blood sample will be taken before surgery, on the first postoperative day and after 3-8 weeks. A Urine sample will be taken after surgery and after 3-8 weeks. Sink and rectal swabs will be acquired before surgery. The samples will be stored in a Biobank. Additionally, all data routinely captured during the treatment of the patient from the different data collection systems in use in the investigators' hospital will be coded and centralized in a single, cohort database
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| InSurg cohort Patients who undergo elective or emergency surgery at the Department of Visceral Surgery and Medicine, Inselspital, Bern, who gave informed consent. |
Diagnostic Test: Blood and urine samples, skin and stool swabs
Blood samples will be collected before surgery, on the first postoperative day and after 3-8 weeks. Urine samples will be collected after surgery and after 3-8 weeks. Stool and skin swabs will be collected before surgery.
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Outcome Measures
Primary Outcome Measures
- Incidence of surgical site infection [30 days]
Number of patients with surgical site infections 30 days postoperatively
Secondary Outcome Measures
- Stool - incidence of surgical site infections [30 days]
Predictive value of preoperative stool sample for surgical site infections
- Urine - incidence of surgical site infections [30 days]
Predictive value of preoperative urine sample for surgical site infections
- Blood - incidence of surgical site infections [30 days]
Predictive value of pre and postoperative plasma metabolome for surgical site infections
- Somatic genomic in surgical site infections [30 days]
Predictive value of somatic genomic variations for surgical site infections
- Informed Consent [3 years]
Rate of inclusion for informed consenting
- Biobanking [3 years]
Rate of inclusion for full biobanking
Other Outcome Measures
- Intraoperative metabolomic Response to surgery [8 weeks]
Metabolome will be extracted from the blood, skin, urine and stool samples analyzed using high resolution mass spectrometry. Metabolomic analysis will be obtained preoperatively in the outpatient setting (elective patients) or at the beginning (emergency patients) and end of the operation. Patterns of metabolites will be evaluated by untargeted analysis.
- Disease-free survival after surgery [3 years]
Disease-free survival after surgery in years will be recorded in oncological patients, and interpreted according to surgical and anesthesia-specific responses after abdominal surgery, in terms of metabolomics analysis of the blood, skin, urine and stool samples, as described above.
- Recurrence-free survival after surgery [3 years]
Recurrence-free survival after surgery in years will be recorded in oncological patients, and interpreted according to surgical and anesthesia-specific responses after abdominal surgery, in terms of metabolomics analysis of the blood, skin, urine and stool samples, as described above.
- Overall survival after surgery [3 years]
Overall survival after surgery in years will be recorded in oncological patients, and interpreted according to surgical and anesthesia-specific responses after abdominal surgery, in terms of metabolomics analysis of the blood, skin, urine and stool samples, as described above.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients undergoing surgery at the Department of Visceral Surgery and Medicine, Inselspital, University Hospital Bern
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Who gave General consent
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Study-specific written informed consent
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beldi Guido | Bern | Switzerland | 3010 |
Sponsors and Collaborators
- University Hospital Inselspital, Berne
Investigators
- Principal Investigator: Guido Beldi, University Hospital Inselspital, Berne
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2019-00576